The Synthes 2.7 mm/ 3.5 mm VA-LCP Anterior Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

Device Description

The Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System consists of plates of various lengths and variable angle screws that provide the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole. The system features medial and lateral plates that are precontoured to match the anatomy of the clavicle and a limited contact, low profile design. The plate with lateral extension features Variable Angle (VA) Locking holes and Dynamic Compression Plate (DCP) holes. The medial plate features Dynamic Compression Plate (DCP) holes combined with VA locking screw holes.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System. This is a bone fixation appliance used in orthopedic surgery, not a diagnostic or AI-driven device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/diagnostic device is not applicable directly to this submission. The "acceptance criteria" here relate to demonstrating substantial equivalence to predicate devices for regulatory approval, primarily through mechanical testing and comparison of design characteristics.

Here’s an adaptation of your requested table and information, focusing on what is available in the document for this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance (Adapted for Medical Device Equivalence)

Acceptance Criteria (for Substantial Equivalence to Predicates)	Reported Device Performance (Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System)
Indications for Use: Comparable to predicate devices, with potential for broader indications if justified.	Same as predicate, with an added pediatric indication (adolescents 12-21 years with fused growth plates or plates not crossing growth plates).
Technological Characteristics: Similar materials, design features, and functionality to predicate devices.	- Machined metal plates (same alloys as predicates).- Pre-contoured for the clavicle.- Incorporate combination dynamic compression/threaded locking screw holes.- Similar geometric dimensions (thickness, shaft width, overall length, number of screw holes).- Limited contact designs.- Allow additional contouring.- Allow the same size cortex, locking cortex, and cancellous screws.
Performance (Mechanical/Engineering): Equivalent or superior mechanical performance to predicate devices in relevant tests.	Static Compression ultimate load strength testing: Showed "much higher bending strength" than predicate plate systems.Engineering Calculations: Confirmed bending strength is "greater than the bending strength of the predicate plate system."
Safety and Effectiveness: Presents no new issues of safety or effectiveness compared to predicate devices.	Based on design characteristics and test results, the device "presents no new issues of safety or effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify exact sample sizes for the "Static Compression ultimate load strength testing." It refers to "the proposed plate system (plate/screw construct)" and "the predicate plate systems" in a general sense, implying typical engineering test runs but not providing specific numbers of constructs tested.
Data Provenance: The testing and engineering analysis were performed by Synthes (USA), a medical device manufacturer. This data is part of their internal validation and verification processes for their product development.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This concept is not directly applicable to this type of device submission. The "ground truth" for mechanical testing is established by engineering standards, test methods, and material science principles, not by expert consensus in a clinical sense. The experts involved would be engineers, material scientists, and regulatory affairs personnel within Synthes and at the FDA, reviewing the data against established benchmarks for mechanical stability and equivalence.

4. Adjudication Method for the Test Set

Not applicable in the AI/diagnostic sense. Mechanical testing results are objective measurements against defined criteria. Any "adjudication" would involve review by subject matter experts (engineers) to ensure test protocols were followed and results interpreted correctly, but not a concensus process like for clinical image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for diagnostic devices where human interpretation needs to be compared or augmented by an AI. This submission is for a bone fixation plate, which is a surgical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This refers to an AI algorithm's performance without human interaction. This device is a passive mechanical implant.

7. The Type of Ground Truth Used

The "ground truth" for establishing substantial equivalence for this device is based on objective mechanical performance metrics (e.g., ultimate load strength, bending strength) derived from standardized engineering tests (e.g., static compression testing) and comparative analysis of design and material properties against legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The design of the plate is based on anatomical considerations and biomechanical engineering principles, informed by previous product development and clinical experience with bone fixation.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set in the AI sense, there is no corresponding ground truth establishment process.

Summary of the Study Proving Device Meets "Acceptance Criteria" for Substantial Equivalence:

The document indicates that the Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System demonstrated substantial equivalence through:

Comparison of Design Characteristics: The device shares core technological characteristics, materials (same alloys), and geometric aspects with its predicate devices (Synthes 3.5mm LCP Reconstruction Plate System, K000684, and Synthes 3.5mm LCP Superior Anterior Clavicle Plate System, K073186). This includes features like pre-contoured plates, combination screw holes, limited contact designs, and compatibility with standard screws.
Mechanical Testing and Engineering Analysis:
- Static Compression ultimate load strength testing was performed on plate/screw constructs.
- Engineering Calculations were used to further confirm performance.
- These tests showed that the proposed plate system exhibited "much higher" and "greater" bending strength compared to the predicate plate systems.

These lines of evidence, reviewed by the FDA, supported the conclusion that the device is substantially equivalent to the predicates and presents no new issues of safety or effectiveness, allowing for its 510(k) clearance.

Summary

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510(k) Summary

Date Prepared:	09/15/2010Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-5000	SEP 1 5 2010
Contact:	Lisa GraneySynthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-1286
Device Name:	2.7/3.5mm VA-LCP Anterior Clavicle Plate System
Classification:	Class II. §888.3030 - Single/multiple component metallic bone fixationappliances and accessories
Predicate Device:	Synthes 3.5mm LCP Reconstruction Plate System, K000684Synthes 3.5mm LCP Superior Anterior Clavicle Plate System, K073186
Device Description:	The Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate Systemconsists of plates of various lengths and variable angle screws that providethe flexibility to lock screws in trajectories that can diverge from thecentral axis of the plate hole.
	The system features medial and lateral plates that are precontoured tomatch the anatomy of the clavicle and a limited contact, low profiledesign. The plate with lateral extension features Variable Angle (VA)Locking holes and Dynamic Compression Plate (DCP) holes. The medialplate features Dynamic Compression Plate (DCP) holes combined withVA locking screw holes.
Indications for Use:	The Synthes 2.7 mm/ 3.5 mm VA-LCP Anterior Clavicle Plate System isindicated for fixation of fractures, malunions, non-unions, and osteotomiesof the clavicle in adults, and in both adolescents (12-18 years) andtransitional adolescents (18-21 years), in which the clavicular growthplates have fused or in which the growth plates will not be crossed by theplate system.

Premarket Notification 510(k): K101536 Synthes (USA) 2.7/3.5mm VA-LCP Anterior Clavicle Plate System

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Substantial Equivalence:

Comparison of design characteristics, test results, and engineering analysis supports substantial equivalence of the Synthes 2.7/3.5mm VA-LCP Anterior Clavicle plate System to the predicate devices stated.

. Indications for Use- are the same except that a pediatric indication has been added to the proposed plate.
Technological Characteristics- The predicate systems and the proposed . systems:
- O Are machined metal plates made from the same alloys.
- Are pre-contoured for the clavicle. o

510(k) Summary (continued)

Incorporate combination dynamic compression/threaded locking O screw holes.
Have similar geometric dimensions- thickness, shaft width, overall 0 length, and number of screw holes.
o Have limited contact designs for minimization of vascular trauma.
Allow additional contouring. O
Allow the same size cortex, locking cortex, and cancellous screws. 0
. Testing/Engineering Analysis:
- Static Compression ultimate load strength testing showed that the 0 proposed plate system (plate/screw construct) has a much higher bending strength than that of the of the predicate plate systems.
- Engineering Calculations confirms that the bending strength of the o proposed plate system is greater than the bending strength of the predicate plate system.

Based on these results, the proposed 2.7/3.5 mm VA-LCP Anterior Clavicle plate system presents no new issues of safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, symbolizing the department's mission to protect and promote the health of Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Synthes (USA) % Ms. Lisa Graney 1301 Goshen Parkway West Chester, Pennsylvania 19380

SEP 1 5 2010

Re: K101536

Trade/Device Name: 2.7/3.5mm VA-LCP Anterior Clavicle Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and appliances

Regulatory Class: II Product Code: HRS, HWC Dated: August 16, 2010 Received: August 16, 2010

Dear Ms. Graney:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Lisa Graney

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

faibare Buem

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K101536

SEP 1 5 2010

510(k) Number (if known):

Device Name:

2.7/3.5mm VA-LCP Anterior Clavicle Plate System

Indications for Use:

Prescription Use X (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Souta for mxn
(Division Sign-off)

Division of Surgical, Othopedic, and Restorative Devices

510(k) Number K101536

Premarket Notification 510(k): Synthes (USA) 2.7/3.5mm VA-LCP Anterior Clavicle Plate System Page 1 of 1

CONFIDENTIAL

2.0

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.